Vaccines, Blood & Biologics
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ACAM2000
STN: BL 125158
Proper Name: Smallpox (Vaccinia) Vaccine, Live
Tradename: ACAM2000
Manufacturer: Sanofi Pasteur Biologics Co., License No. 1815
Indication:
- Active immunization against smallpox disease for persons determined to be at high risk for smallpox infection.
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Product Information
Package Insert - ACAM2000 (PDF - 285KB)
September 2009Medication Guide - ACAM2000 (PDF - 83KB)
October 2009
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Supporting Documents
May 5, 2010 Approval Letter - ACAM2000
Revisions: Change in the package insert, carton, vial, container and medication guide labeling for administrative changes and/or correction of inadvertent errors.August 31, 2007 Approval Letter - ACAM2000
Active immunization against smallpox disease for persons determined to be at high risk for smallpox infection.
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Related Information
FDA Approves Second-Generation Smallpox Vaccine
Press Release: September 1, 2007ACAM2000 (Smallpox Vaccine) Questions and Answers FDA Online Label Repository
Search this database for drug labeling and other information. The content has not been altered or verified by the FDA and may not be the labeling on currently distributed products or identical to the labeling that is approved.
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Contact FDA
(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448
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